Clinical trial · Interventional
Conditions of Diagnostic Panendoscopy of the Upper Airway Under Propofol Remifentanil General Anesthesia
Evaluation of the Impact of Adding Remifentanil to Propofol on the Conditions of the Diagnostic Panendoscopy of the Upper Airway Under General Anesthesia With Tubeless Spontaneous Ventilation.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The most important considerations for the general anesthesia in diagnostic panendoscopy of the upper airway is the maintenance of a patient's airway for optimal surgical exposure, adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques with preserved spontaneous ventilation and total intravenous administration of anesthetic drugs are widely use. Due to its pharmacological profile, propofol anesthesia is often considered as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous studies suggested that adding remifentanil to propofol could improve the conditions for laryngoscopy and tracheal intubation. The aim of this study is to assess the impact of propofol remifentanil general anesthesia compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of the upper airway.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor of Ear, Nose and Throat | Ear Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remifentanil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Remifentanil
- description
- The general anesthesia during the diagnostic panendoscopy of the upper airway will associate the target controlled infusion of propofol (pharmacologic model of Schnider et al.) and of remifentanil (pharmacologic model of Minto et al.) in the remifentanil group. The arm will be randomized prior to the beginning of the surgical procedure and blinded to the investigator and to the practitioner in charge of the patient. Two milligrams of remifentanil will be diluted in 40 cc of sodium chloride 0,9% in a 50 ml syringe.
- interventionNames
- Drug: Remifentanil
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The general anesthesia during the diagnostic panendoscopy of the upper airway will consist in the target controlled infusion of propofol alone (pharmacologic model of Schnider et al.) in the placebo group. The placebo is a 40 ml sodium chloride 0,9% solution in a 50 ml syringe. No one can distinguish the syringe of placebo from the syringe of remifentanil.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Elective diagnostic panendoscopy of the upper airway * Age \> 18 and \< 80 years old * American Society of Anesthesiology (ASA) score equal to 1, 2, or 3 with a stable condition * Written inform consent Exclusion Criteria: * Pregnancy or breastfeeding * Age \< 18 years old or inability to give informed consent * Known anaphylaxis to remifentanil or propofol * Long term opioid use, drug abuse * Predictive criterion of impossible mask ventilation or intubation * Chronic respiratory failure requiring oxygen therapy
References
Publications (3)
- BACKGROUNDSchnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82. doi: 10.1097/00000542-199805000-00006. PMID 9605675
- BACKGROUNDMinto CF, Schnider TW, Egan TD, Youngs E, Lemmens HJ, Gambus PL, Billard V, Hoke JF, Moore KH, Hermann DJ, Muir KT, Mandema JW, Shafer SL. Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanil. I. Model development. Anesthesiology. 1997 Jan;86(1):10-23. doi: 10.1097/00000542-199701000-00004. PMID 9009935
- BACKGROUNDMinto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005. PMID 9009936